CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U), Dexamethasone (UNII: 7S5I7G3JQL) (Dexamethasone - UNII:7S5I7G3JQL)

Available from:

Sandoz Inc

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Risk Summary There are no available data on ciprofloxacin and dexamethasone otic suspension use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal, or fetal outcomes. Because of the minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration of ciprofloxacin and dexamethasone otic suspension, this product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women [see Clinical Pharmacology (12.3)]. Animal reproduction studies have not been conducted with ciprofloxacin and dexamethasone otic suspension. Oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal mal

Product summary:

How Supplied Ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension is a white-to off-white suspension supplied as follows: 7.5 mL fill in a system consisting of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package. 7.5 mL fill          NDC 0781-6186-67 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Protect from light.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CIPROFLOXACIN AND DEXAMETHASONE- CIPROFLOXACIN AND
DEXAMETHASONE SUSPENSION/ DROPS
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN AND
DEXAMETHASONE OTIC SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION.
CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Ciprofloxacin and dexamethasone otic suspension is a combination of
ciprofloxacin, a fluoroquinolone
antibacterial and dexamethasone, a corticosteroid, indicated for the
treatment of infections caused by
susceptible isolates of the designated microorganisms in the specific
conditions listed below:
•
•
DOSAGE AND ADMINISTRATION
Ciprofloxacin and dexamethasone otic suspension is for otic use (ears)
only, not for ophthalmic use, or for
injection. (2.1)
•
•
DOSAGE FORMS AND STRENGTHS
Otic Suspension: Each mL of ciprofloxacin and dexamethasone otic
suspension contains ciprofloxacin
hydrochloride 0.3% (equivalent to 3 mg ciprofloxacin base) and
dexamethasone 0.1% (equivalent to 1 mg
dexamethasone). (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reactions were ear discomfort (3%), ear pain
(2.3%), and ear pruritus (1.5%). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC., AT
1-800-525-8747 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 11/2020
Acute Otitis Media (AOM) in pediatric patients (age 6 months and
older) with tympanostomy tubes
due to _Staphylococcus aureus_, _Streptococcus pneumoniae_,
_Haemophilus influenzae_, _Moraxella_
_catarrhalis_, and _Pseudomonas aeruginosa_. (1)
Acute Otitis Externa (AOE) in pediatric (age 6 months and older),
adult, and elderly patients due to
_Staphylococcus aureus _and _Pseudomonas aeruginosa_. (1)
Shake well immediately before use. (2.1)
Instill four drops into t